International Journal of Pharmacy
|
|
- Thomasina Hampton
- 6 years ago
- Views:
Transcription
1 International Journal of Pharmacy Journal Homepage: Research Article CDEN: IJPNL6 PLASMA PRTEIN BINDING STUDY F METAXALNE WITH HUMAN PLASMA BY RP-HPLC Kasture Veena S, Mhaske Sharayu D*, Pathan Mallika A, Waman Nitesh, Ajage Rohit K Department of Quality Assurance Techniques, Sanjivani College of Pharmaceutical Education and Research, Kopargaon, MS, India *Corresponding author sharayumhaske@yahoo.com ABSTRACT The HPLC method was developed and validated to quantify Metaxalone binding with human plasma. Metaxalone was extracted from spiked plasma by simple protein precipitation with methanol. The seperation was performed on RP-C18 column with mobile phase of HPLC grade methanol at a flow rate of 1 ml/min. The peak of Metaxalone was monitored at 272 nm with UV-VIS detector. The calibration curve was found to be linear at concentration range of 1-8 μg/ml. Regression was found to be The interday and intraday precisions SD and RSD were and 0.515, 1.851% and 1.648%. respectively. The recovery of Metaxalone from formulation was 96.97±2.14% and from plasma was found to be 84%. Plasma protein binding was found to be 16.90±1.67. The developed method was validated as per ICH guidelines.the simple, rapid, sensitive and reproducible HPLC method was developed for estimation of Metaxalone plasma protein binding.. The proposed method can be used for the pharmacokinetic and bioequivalence studies of Metaxalone. Keywords: Metaxalone, HPLC method development, Plasma Protein binding, Human plasma. INTRDUCTIN Metaxalone is 5-[(3,5 dimethylphenoxy)methyl]-2- oxazolidinone with molecular formula C 12 H 15 N 3 and molecular weight of , a skeletal muscle relaxant drug marketed by King pharmaceuticals. Skeletal muscle relaxants have been used for either treatment of spasticity or for treatment of musculoskeletal conditions. Metaxalone is used to relax muscles and relieve pain caused by strains, sprains, and other musculoskeletal conditions. Its exact mechanism of action is not known but it may be due to general central nervous system depression. [1,2] Protein binding of Metaxalone is not known [1]. Literature survey revealed that only few methods were reported for quantification of Metaxalone in plasma by liquid chromatography. [3] These methods reported the recovery of Metaxalone from plasma but no method reported about binding of Metaxalone to human plasma. Since the protein binding study was not much reported for Metaxalone, in present study, the human plasma protein binding of Metaxalone was studied. The developed chromatographic seperation method is useful for pharmacokinetic and bioequivalence studies of Metaxalone containing formulations. [4] MATERIALS AND METHDS Instruments 1. HPLC, SHIMADZU (isocratic) with LC-20 AD pump, SPD-20A detector system and spinchrom software 2. Cyclomixer, 101 Remi 3. Centrifuge, Remi 4. Sonicator, Sidilu ultrasonics-1.5l50h Materials Standard Metaxalone was obtained as a gift sample from Angelini pharmaceuticals Ltd. and HPLC grade methanol was obtained from Research lab fine chem industry, Mumbai. Drug free human plasma was purchased from local blood bank of Kopargaon
2 Tablets of Metaxalone (FLEXURA 400 Sun pharma Sikkim), were procured from local market of Kopargaon. Preparation of standard stock solution: Stock solution of Metaxalone was prepared in methanol at a concentration of 100 μg/ml and was kept at C. Stock solution was diluted with methanol to obtain the concentrations of 1-8 μg/ml. Preparation of Quality Control Standards: Lowest quality control standards (LQC), median quality control standards (MQC) and highest quality control standards (HQC) were prepared by spiking 0.25 ml drug free plasma with Metaxalone to give samples containing 3, 5, 8 μg/ml of Metaxalone respectively and were stored at 4 0 C till analysed. [5] Chromatographic conditions: 6 The chromatographic seperation of Metaxalone was done using RP-C18 (250mmx4.6mm), 5μ column(phenomenex). The mobile phase was HPLC grade methanol. Flow rate was maintained at 1ml/min. Total run time of analysis was 10 min.the peaks were determined using UV-VIS detector set at a wavelength of 272 nm. Retention time was found to be min. Injection volume was 20 μl. All the procedures were performed at ambient temperature. The mobile phase was selected after trial and error basis in which the composition of methanol, water and acetonitrile were tried but sharp peak was not resulted. The asymmetry of peak was minimum with pure methanol. Extraction procedure for plasma protein binding study [7] Appropriate quantity of metaxalone solution was spiked with 0.25 ml of plasma to produce 1-8 μg/ml. The mixture was vortexed for 2 min. and kept overnight. n next day the mixure was centrifuged at 4000 rpm for 30 min. The supernatant solution was seperated from settled plasma. 10ml of methanol was added to settled plasma and was vortexed for 30 min. for complete extraction of Metaxalone from plasma. The PTFE syring filter was firstly preconditioned with methanol. and extracted Metaxalone solution was passed through 0.45 μ PTFE Syringe filter. The resultant filtrate of 20 μl was injected into HPLC system for analysis. HPLC method validation [8] System suitability parameters: The AUC of respective concentrations, theoretical plates (Efficiency), peak symmetry (Tailing factor) was recorded. Linearity: Dilutions of standard solution of metaxalone in the range of 1-8 μg/ml were prepared by taking suitable aliquots of standard solutions in different 10 ml of volumetric flasks and diluting upto the mark with methanol. 20 μl of the resultant was injected, at each time into the column at flow rate of 1ml/min. the standard solution was monitored at 272 nm. A plot of peak area over concentration was constructed. Regresssion of the plot was computed by least square regresssion method of analysis. Precision: Precision of analytical method was studied by multiple injection of homogeneous sample. 5 replicates of 3 ppm were prepared and injected for precision at same flow rate of 1 ml/min. the SD and %RSD were calculated. Robustness: Robustness was studied by changing parameters like change in flow rate. The flow rate was kept 0.8 ml/min. The SD and %RSD were calculated. Ruggedness: Analyst was changed for ruggedness study. The SD and %RSD were calculated LD and LQ: Limit of detection and limit of quantitation of method was calculated by formula given below LD=3.3x SD / Slope LQ=10x SD / Slope Accuracy:Accuracy of the method was studied using the standard addition method. The % recovery was determined at three different levels (50%, 100% and 150%). RESULTS AND DISCUSSIN Develpoment and Validation of HPLC method The Metaxalone peak was appeared at min. (Figure 1). The system suitability parameters for developed HPLC method was stated in table 1. The HPLC method was developed and validated for analysis of Metaxalone plasma binding. Calibration curve showed linear relationship between concentration and area at 272 nm in concentration range of 1-8μg/ml. The regression was found to be The regression equation was y= x (Figure 2). Standard deviation and % RSD for precision was found to be and 1.532% respectively. Standard deviation and % RSD for interday and intraday precision was found to be 0.576, 1.851% and % respectively. The standard deviation and %RSD for ruggedness and robustness were found to be 0.476, 1.533% and 0.569, 1.817% respectivly (Table 2). Limit of detection was found to be 0.152μg/ml and limit of quantitation was found to be μg/ml. Accuracy 200
3 was found to be 96.97% (Table 3). The values were within the limit specified by ICH guidelines. Hence method was found to be precise, rugged and robust. [8] Plasma protein binding study of Metaxalone: Percentage of plasma protein binding was calculated by: %protein binding = Area of bound drug x100 Area of standard drug Plasma protein binding of Metaxalone was found to be 16.90±1.67%. CNCLUSIN Metaxalone is poorly water soluble muscle relaxant drug of which protein binding is not reported in literature. In the proposed study Metaxalone binding with human plasma (in vitro) was studied. The plasma binding was quantified by validated isocratic HPLC method. Plasma protein binding of Metaxalone was found to be 16.90%. The developed method was sensitive, accurate, precise bioanalytical method. The proposed method canbe successfully applied for pharmacokinetic and bioequivalence studies. ACKNWLEDGEMENTS We wish to express our sincere thanks to Dr. Kasture Sanjay B. Principal, Sanjivani College of Pharmaceutical Education and Research, Kopargaon for providing necessary facilities. HN H 3 C CH 3 Metaxalone Figure 1: Chromatogram of Standard 5 ppm Metaxalone Figure 2: Calibration curve of Metaxalone at 272 nm (Concentration vs. Area) 201
4 Figure 3: Chromatogram of Metaxalone bound to plasma (3ppm) Figure 4: Chromatogram of Metaxalone bound to plasma (5ppm) Figure 5: chromatogram of Metaxalone bound to plasma (8 ppm) Table 1:Results of system suitability parameters Sr. no. Concentration (ppm) Retention Time Asymmetry Efficiency Table 2: Results of Precision by HPLC Parameters SD %RSD Precision % Interday Precision % Intraday Precision % Ruggedness % Robustness % 202
5 Table 3: Results of accuracy by HPLC Sr No Concentration (ppm) 1ppm test+2ppm standard 1ppm test+3ppm standard 1ppm test+4ppm standard Mean Area Area of standard %Recovery 94.66% % 98.91% Table 4: Summary of HPLC Method validation Sr no. Parameter bservation 1. Linearity range 1-8 μg/ml 2. Slope Intercept Correlation Coefficient Precision SD %RSD Interday Precision SD %RSD Intraday Precision SD %RSD Ruggedness SD Robustness %RSD SD %RSD Accuracy 96.97% 11. LD 0.152μg/ml 12. LQ 0.461μg/ml Table 5: Results for plasma protein binding of Metaxalone Sr. no. Concentration Mean area of Area of std. % Binding (ppm) bound drug drug % % % REFERENCES 1. DrugBank, pen Data Drug and Drug Target Database approved by FDA, 2. Wikipedia: The Free Encyclopedia, 3. Karthikeyan Kandasamy, Vasantharaju Surenahalli Gowdra, Hariprabhu Nammalvar, Arulkumaran Kottur S Govindarajan. J. Bioanal Biomed, 2012; S6: Pavan Balabathula, Dileep R Janagam, Nivesh K Mittal, Bivash Mandal, Laura A Thoma and George C Wood. J. Bioequiv Availab, 2013; 5(3): Guidance for Industry Bioanalytical Method Validation, U.S. Department of Health and Human Services FDA, CDER, CVM, BP 2001; Khan Imran, Saraf Madhusudan Natvarlal, Sayyed Nazim. Int. J. ChemTech Res, 2011; 3(4): Dhaval S. Thakar, Alice Varghese. Int. J. Pharm. Biosci. Technol, 2013; 1(1): ICH Q2B: Guidance for Industry: Validation of Analytical procedures:methodology, U. S. Department of Health and Human services Food and Drug Administration, CDER, CBER, 1996;
N. Tamilselvi *, Dona Sara Kurian. Department of Pharmaceutical Analysis. KMCH college of pharmacy Coimbatore
BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF PIRFENIDONE BY RPHPLC METHOD AND ITS APPLICATION TO THE DETERMINATION OF DRUG FOOD INTERACTION STUDY IN WISTER RATS ABSTRACT N. Tamilselvi *, Dona Sara
More informationRP-HPLC METHOD FOR QUANTITATIVE ESTIMATION OF GLATIRAMER ACETATE FOR INJECTION IN PHARMACEUTICAL DOSAGE FORMS
RP-HPLC METHOD FOR QUANTITATIVE ESTIMATION OF GLATIRAMER ACETATE FOR INJECTION IN PHARMACEUTICAL DOSAGE FORMS ABSTRACT A simple RP-HPLC method for the determination of Glatiramer acetate in pharmaceutical
More informationValidated Stability-indicating assay method for determination of Ilaprazole in bulk drug and tablets by high performance liquid chromatography
Validated Stability-indicating assay method for determination of Ilaprazole in bulk drug and tablets by high performance liquid chromatography Pradeep G. Shelke a*, Anil V. Chandewar a, Anil P. Dewani
More informationResearch Paper Development of Stability Indicating Reverse Phase HPLC Method for Aripiprazole from Solid Dosage form
International Journal of Pharmaceutical Sciences and Nanotechnology 572 International Journal of Pharmaceutical Sciences and Nanotechnology Volume 2 Issue 2 July - September 2009 Volume 2 Issue 2 July
More informationAvailable Online through (or) IJPBS Volume 2 Issue 3 JULY-SEPT Research Article Pharmaceutical Sciences
Page1 Research Article Pharmaceutical Sciences RP-HPLC DETERMINATION OF RELATED SUBSTANCES OF TAPENTADOL IN BULK AND PHARMACEUTICAL DOSAGE FORM EDIGA SASI KIRAN GOUD* 1, V.KRISHNA REDDY 2 * 1,2 Department
More informationSize Exclusion Chromatography of Biosimilar and Innovator Insulin Using the Agilent AdvanceBio SEC column
Size Exclusion Chromatography of Biosimilar and Innovator Insulin Using the Agilent AdvanceBio SEC column Application Note Bio-Pharmaceutical Authors M. Sundaram Palaniswamy and Andrew Coffey Agilent Technologies,
More informationDevelopment & Validation of RP-HPLC Method for Estimation of Dabigatran Etexilate Mesylate from Capsule Dosage Form
Development & Validation of RP-HPLC Method for Estimation of Dabigatran Etexilate Mesylate from Capsule Dosage Form Bhavna Patel 1,Shoumik Roy 1,Hardik Ghelani 2, Shraddha Parmar 1 * 1 Post Graduation
More informationInternational Journal of Pharma Research & Review, Feb 2014; 3(2):11-16 ISSN:
Research Article Determination of Methyl Methanesulfonate, Ethyl Methanesulfonate and Isopropyl Methanesulfonate Impurities in Lopinavir API by GC/MS/MS using Electron Ionization Veenaeesh P, *Manikumar
More informationDeveloping Robust and Efficient IEX Methods for Charge Variant Analysis of Biotherapeutics Using ACQUITY UPLC H-Class System and Auto Blend Plus
Developing Robust and Efficient IEX Methods for Charge Variant Analysis of Biotherapeutics Using ACQUITY UPLC H-Class System and Auto Blend Plus Robert Birdsall, Thomas Wheat, and Weibin Chen Waters Corporation,
More informationDevelopment of Quality Control Method for Dissolution Analysis of Tapentadol and paracetamolin tablet
Original Research Article Development of Quality Control Method for Dissolution Analysis of Tapentadol and paracetamolin tablet Krishna R Gupta 1,*, Kiran N. Kale 2 1 Professor, 2 Phd. Scholar, SKB College
More informationResearch Article Development and Validation of Acyclovir HPLC External Standard Method in Human Plasma: Application to Pharmacokinetic Studies
Advances in Pharmaceutics, Article ID 284652, 5 pages http://dx.doi.org/10.1155/2014/284652 Research Article Development and Validation of Acyclovir HPLC External Standard Method in Human Plasma: Application
More informationA green HPLC technique with a 100% water mobile phase for detecting imidacloprid and its metabolite 6-chloronicotinic acid
Current Chemistry Letters 5 (2016) 27 32 Contents lists available atgrowingscience Current Chemistry Letters homepage: www.growingscience.com/ccl A green HPLC technique with a 100% water mobile phase for
More informationInternational Journal of Medicine and Nanotechnology
International Journal of Medicine and Nanotechnology Access online at www.medtechnano.com Original Article Method Development and Validation for the Simultaneous Estimation of Doxycycline and Ornidazole
More informationValidation of a concentration assay using Biacore C
GE Healthcare Application Note 48 Biacore systems Validation of a concentration assay using Biacore C Guideline for development of a GxP - compliant concentration assay Support for informed decision-making
More informationQuantitative determination of residual 2-(2-chloroethoxy) ethanol (CEE) in quetiapine fumarate by gas chromatogaraphy
Advances in Bioscience and Biotechnology, 2010, 1, 367-371 doi:10.4236/abb.2010.15049 Published Online December 2010 (http://www.scirp.org/journal/abb/). Quantitative determination of residual 2-(2-chloroethoxy)
More informationA Sub-picogram Quantification Method for Desmopressin in Plasma using the SCIEX Triple Quad 6500 System
A Sub-picogram Quantification Method for Desmopressin in Plasma using the SCIEX Triple Quad 6500 System A high-throughput method for detecting ultra-low levels (0.5 pg/ml) of a therapeutic peptide in human
More informationINTERNATIONAL PHARMACOPOEIA MONOGRAPH ON ARTEMETHER AND LUMEFANTRINE CAPSULES REVISED DRAFT FOR DISCUSSION
October 2007 RESTRICTED ` INTERNATIONAL PHARMACOPOEIA MONOGRAPH ON ARTEMETHER AND LUMEFANTRINE CAPSULES REVISED DRAFT FOR DISCUSSION World Health Organization 2007 All rights reserved. This draft is intended
More informationMethod development and validation for the quantitative estimation of cefixime and ofloxacin in Pharmaceutical preparation by RP- HPLC
Available online at www.derpharmachemica.com Scholars Research Library Der Pharma Chemica, 2014, 6(2):31-37 (http://derpharmachemica.com/archive.html) ISSN 0975-413X CODEN (USA): PCHHAX Method development
More informationHPLC METHODOLOGY MANUAL
HPLC METHODOLOGY MANUAL DISTRIBUTED PHARMACEUTICAL ANALYSIS LABORATORY (DPAL) Revision Date 2016-08-04 Professor Marya Lieberman Department of Chemistry and Biochemistry University of Notre Dame Notre
More informationForced degradation studies and validated stability indicating HPTLC method for determination of miconazole nitrate in soft lozenges
Available online at www.scholarsresearchlibrary.com Scholars Research Library Der Pharmacia Lettre, 2012, 4 (6):1793-1804 (http://scholarsresearchlibrary.com/archive.html) ISSN 0975-5071 USA CODEN: DPLEB4
More informationKalyani G. et al.; International Journal of Pharmamedix India, 2013, 1(2),
Kalyani G. et al.; International Journal of Pharmamedix India, 2013, 1(2), 222-232. Stability Indicating Method Development and Validation of Candesartan in Bulk and Pharmaceutical Dosage Form by Derivative
More informationBioanalytical method validation: An updated review
Review Article www.phmethods.org Bioanalytical method validation: An updated review Abstract The development of sound bioanalytical method(s) is of paramount importance during the process of drug discovery
More informationResearch Article. Optimization and validation of rapid and simple method for determination of Isoniazid and Pyrazinamide in plasma by HPLC-UV
Available online www.jocpr.com Journal of Chemical and Pharmaceutical Research, 2016, 8(3):165-169 Research Article ISSN : 0975-7384 CODEN(USA) : JCPRC5 Optimization and validation of rapid and simple
More informationQbD approach for analytical method development of anti-pschotic drug
Available online at www.scholarsresearchlibrary.com Scholars Research Library Der Pharmacia Lettre, 2015, 7 (12):62-70 (http://scholarsresearchlibrary.com/archive.html) ISSN 0975-5071 USA CODEN: DPLEB4
More informationFusion Analytical Method Validation
Fusion QbD Software System Fusion Analytical Method Validation The Only Software That Has It All! 100% aligned with FDA/ICH Quality by Design (QbD) guidances! Can be used for LC and Non-LC methods (e.g.
More informationQuality-by-Design-Based Method Development Using an Agilent 1290 Infinity II LC
Quality-by-Design-Based Method Development Using an Agilent 129 Infinity II LC An Efficient Method Development Workflow Combined with ISET-mediated Method Transfer Under Waters Empower 3 CDS Control Application
More informationDetermination of Adenovirus pviii (31K) Concentration for Estimation of the Empty Capsid Concentration of the Adenovirus Reference Material (ARM)
Determination of Adenovirus pviii (31K) Concentration for Estimation of the Empty Capsid Concentration of the Adenovirus Reference Material (ARM) Sundari Ravindran, Mei Lin, Gary Vellekamp, (SPRI) Summary:
More informationOptimizing the Purification of a Standard Chiral Compound Utilizing a Benchtop, Multi-Purpose, Semi-Preparative to Preparative HPLC System
Optimizing the Purification of a Chiral Compound Utilizing a Benchtop, Multi-Purpose, Semi-Preparative to Preparative HPLC System Application Note PHA0111 Keywords Chiral, Enantiomer, HPLC, Normal Phase
More informationVICH Topic GL2 (Validation: Methodology) GUIDELINE ON VALIDATION OF ANALYTICAL PROCEDURES: METHODOLOGY
The European Agency for the Evaluation of Medicinal Products Veterinary Medicines Evaluation Unit CVMP/VICH/591/98-FINAL London, 10 December 1998 VICH Topic GL2 (Validation: Methodology) Step 7 Consensus
More informationA Modular Preparative HPLC System for the Isolation of Puerarin from Kudzu Root Extracts
A Modular Preparative HPLC System for the Isolation of Puerarin from Kudzu Root Extracts Andrew Aubin and Ronan Cleary Waters Corporation, Milford, MA, USA APPLICATIN BENEFITS A modular preparative HPLC
More informationPeptide Mapping: A Quality by Design (QbD) Approach
Peptide Mapping: A Quality by Design (QbD) Approach Application Note Bio-Pharmaceutical Authors Sreelakshmy Menon and Suresh babu C.V. Agilent Technologies, Inc. Richard Verseput S-Matrix Corporation Abstract
More informationImproving Resolution and Column Loading Systematically in Preparative Liquid Chromatography for Isolating a Minor Component from Peppermint Extract
Improving Resolution and Column Loading Systematically in Preparative Liquid Chromatography for Isolating a Minor Component from Peppermint Extract Jo-Ann M. Jablonski and Rui Chen Waters Corporation,
More informationChem 321 Lecture 23 - Liquid Chromatography 11/19/13
Chem 321 Lecture 23 - Liquid Chromatography 11/19/13 Student Learning Objectives High Performance Liquid Chromatography With the advent of relatively inexpensive and reliable pumps, the development of
More informationDETERMINATION OF MYCOTOXINE DEOXYNIVALENOL IN WHEAT FLOUR AND WHEAT BRAN
Revue de Cytologie et Biologie végétales-le Botaniste 2005-28 (s.i.): 64-70 DETERMINATION OF MYCOTOXINE DEOXYNIVALENOL IN WHEAT FLOUR AND WHEAT BRAN by F. ISRAEL-ROMING (1) M. AVRAM (2) V. GAGIU (2) G.
More informationDetermination of organochlorine pesticide residues in eggs by gel-permeation chromatography (GPC) cleanup and GC-ECD
Determination of organochlorine pesticide residues in eggs by gel-permeation chromatography (GPC) cleanup and GC-ECD 1. Experimental Section LabTech, Inc. 1.1 Instruments and reagents AutoClean automatic
More informationNovel Rp-Hplc-Pda Method for the Simultaneous Estimation of Metoprolol Succinate and Chlorthalidone in Bulk and Pharmaceutical Dosage Forms
Research Article Novel Rp-Hplc-Pda Method for the Simultaneous Estimation of Metoprolol Succinate and Chlorthalidone in Bulk and Pharmaceutical Dosage Forms A. Naga Jyothi 1, Syed. Sadath Ali 2, Buchi.
More informationPreparative HPLC is still the
B I O P R O C E S S TECHNICAL Optimizing Sample Load Capacity and Separation Through a Series of Short Prep Columns Mark Crawford, Joan Stevens, and Luke Roenneburg Preparative HPLC is still the dominate
More informationCertified Reference Material - Certificate of Analysis
Certified Reference Material - Certificate of Analysis S(-)-Nicotine, Primary Standard N-008 Page 1 of 7 Catalog Number: N-008 H Lot: Expiration: October 2019 N Description: S(-)-Nicotine in Methanol.
More informationDeveloping and Validating Dissolution Procedures for Improved Product Quality
W H I T E P A P E R Developing and Validating Dissolution Procedures for Improved Product Quality By Michael Swartz, Ph. D., Director of Research and Development, and Mark Emanuele, Chemist Abstract In
More informationPAHs in Surface Water by PDA and Fluorescence Detection
A P P L I C AT I O N N O T E Liquid Chromatography Authors: Catharine Layton Wilhad M. Reuter PerkinElmer, Inc. Shelton, CT PAHs in Surface Water by PDA and Fluorescence Detection Introduction Heightened
More informationPhysical Stability of a Silica- Based Size Exclusion Column for Antibody Analysis
Physical Stability of a Silica- Based Size Exclusion Column for Antibody Analysis Atis Chakrabarti* and Roy Eksteen + Tosoh Bioscience LLC, King of Prussia, PA 19406 *Corresponding Author. + Current address:
More informationDetermination of Iron Content in Different Hemoglobin Samples from Some Patients by UV-Visible Spectrophotometer
Advances in Analytical Chemistry 2016, 6(2): 35-40 DOI: 10.5923/j.aac.20160602.01 Determination of Iron Content in Different Hemoglobin Samples from Some Patients by UV-Visible Spectrophotometer Isam Eldin
More informationGenotoxicity is the property of a compound
Impurities Analysis in Pharmaceuticals: Genotoxicity is the property of a compound known to have irreversible effects on the structure and functionality of the DNA in cells and cause DNA loss, DNA replication
More informationAgilent AdvanceBio SEC Columns for Aggregate Analysis: Instrument Compatibility
Agilent AdvanceBio SEC Columns for Aggregate Analysis: Instrument Compatibility Technical Overview Introduction Agilent AdvanceBio SEC columns are a new family of size exclusion chromatography (SEC) columns
More informationDisulfide Linkage Analysis of IgG1 using an Agilent 1260 Infinity Bio inert LC System with an Agilent ZORBAX RRHD Diphenyl sub 2 µm Column
Disulfide Linkage Analysis of IgG1 using an Agilent 126 Infinity Bio inert LC System with an Agilent ZORBAX RRHD Diphenyl sub 2 µm Column Application Note Biotherapeutics & Biosimilars Author M. Sundaram
More informationLaboratory Reagents. for life science research.
Laboratory Reagents Research, quality control, or routine analysis whatever the field of activity, where there is a need for laboratory reagents, Thermo Fisher Scientific has a suitable product. We offer
More informationValidation Report 19
EURL for Cereals and Feeding stuff National Food Institute Technical University of Denmark Validation Report 19 Determination of pesticide residues in oat, rye and wheat by GC-MS/MS and LC-MS/MS (QuEChERS
More informationAPPLICATION NOTE. Application Note. Summary/Abstract:
APPLICATION NOTE Characterization of Gold Nanoparticle Detection Using Slope Spectroscopy (SoloVPE Variable Pathlength UV) Application Note The SoloVPE and Slope Spectroscopy offer a new method of Slope
More informationBIOANALYTICAL METHOD DEVELOPMENT AND ITS VALIDATION
321 P a g e International Standard Serial Number (ISSN): 2319-8141 International Journal of Universal Pharmacy and Bio Sciences 3(4): July-August 2014 INTERNATIONAL JOURNAL OF UNIVERSAL PHARMACY AND BIO
More informationmab Titer Analysis with the Agilent Bio-Monolith Protein A Column
mab Titer Analysis with the Agilent Bio-Monolith Protein A Column Application Note Biopharmaceuticals and Biosimilars Authors Emmie Dumont, Isabel Vandenheede, Pat Sandra, and Koen Sandra Research Institute
More informationA Validated Stability Indicating HPTLC Method for Determination of Cephalexin in Bulk and Pharmaceutical Formulation
International Journal of PharmTech Research CODEN( USA): IJPRIF ISSN : 0974-4304 Vol.1, No.3, pp 527-536, July-Sept 2009 A Validated Stability Indicating HPTLC Method for Determination of Cephalexin in
More informationCharacterization of mab aggregation using a Cary 60 UV-Vis Spectrophotometer and the Agilent 1260 Infinity LC system
Characterization of mab aggregation using a Cary 60 UV-Vis Spectrophotometer and the Agilent 1260 Infinity LC system Application Note Biopharmaceuticals Authors Arunkumar Padmanaban and Sreelakshmy Menon
More informationConcentration of Human Hormones in Drinking Water Using Solid Phase Extraction and Analysis by High Performance Liquid Chromatography
Concentration of Human Hormones in Drinking Water Using Solid Phase Extraction and Analysis by High Performance Liquid Chromatography Carl Fisher, Monika Verma, and Pranathi Perati; Thermo Fisher Scientific,
More informationDEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR DETERMINATION OF MICAFUNGIN AND ITS RELATED SUBSTANCES IN BULK BY RP-UPLC
Joshi et al., IJPSR, 2016; Vol. 7(3): 1211-1218. E-ISS: 0975-8232; P-ISS: 2320-5148 IJPSR (2016), Vol. 7, Issue 3 (Research Article) Received on 16 September, 2015; received in revised form, 05 December,
More informationAPPLICATION NOTE. UOP : Analysis of Trace CO and CO 2 in bulk H 2 and Light Gaseous Hydrocarbons by GC
UOP 63-13: Analysis of Trace CO and CO 2 in bulk H 2 and Light Gaseous Hydrocarbons by GC Fast Analysis in
More informationSensoLyte Anti-alpha-Synuclein Quantitative ELISA Kit (Human/Mouse/Rat) *Colorimetric*
Catalog # Kit Size SensoLyte Anti-alpha-Synuclein Quantitative ELISA Kit (Human/Mouse/Rat) *Colorimetric* AS-55550 One 96-well strip plate This kit is optimized to detect human/mouse/rat alpha-synuclein
More informationINTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH AND BIO-SCIENCE
INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH AND BIO-SCIENCE REVIEW ON RP-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR BIO ANALYSIS OF VERAPAMIL IN RAT PLASMA VIVEK VIJAYAN SPPSPTM, NMIMS University,
More informationSTANDARD OPERATING PROCEDURES
PAGE: 1 of 5 CONTENTS 1.0 SCOPE AND APPLICATION 2.0 METHOD SUMMARY 3.0 SAMPLE PRESERVATION, CONTAINERS, HANDLING, AND STORAGE 4.0 INTERFERENCES AND POTENTIAL PROBLEMS 5.0 EQUIPMENT/APPARATUS 6.0 REAGENTS
More informationInvestigation of Solid Phase Microextraction as an Alternative to Dried Blood Spot
Investigation of Solid Phase Microextraction as an Alternative to Dried Blood Spot Craig Aurand and Robert Shirey Supelco, Div. of Sigma-Aldrich Bellefonte, PA 16823 USA T414068 sigma-aldrich.com/analytical
More informationDRPK-005
1114 Seaco Avenue Deer Park, TX 77536 Ph: (713) 844-3200 Fax: (713) 844-3330 Report of Analysis Submitted By: Address: Contact: Item No.: Client Ref. No.: Date Received: Testing Period: Country of Origin:
More informationImproved SPE for UPLC/MS Determination of Diquat and Paraquat in Environmental
Improved SPE for UPLC/MS Determination of Diquat and Paraquat in Environmental Samples Michael S.Young, Jeremy C. Shia, Kim vantran, Kevin M. Jenkins and Masayo Yabo Waters Corporation 34 Maple Street,
More informationMethod Development and Validation for Online UV-Dissolution Methods Using Fiber-Optic Technology
Technical Overview Method Development and Validation for Online UV-Dissolution Methods Using Fiber-Optic Technology Introduction Online fiber-optic and multicell UV-dissolution systems have become increasingly
More informationFormulas: See Table 1 MW: Table 1 CAS: Table 1 RTECS: Table 1. METHOD: 2555, Issue 1 EVALUATION: PARTIAL Issue 1: 15 March 2003
KETONES I 2555 Formulas: See Table 1 MW: Table 1 CAS: Table 1 RTECS: Table 1 METHOD: 2555, Issue 1 EVALUATION: PARTIAL Issue 1: 15 March 2003 OSHA : See Table 2 NIOSH: See Table 2 ACGIH: See Table 2 PROPERTIES:
More informationApplication Note. Author. Abstract. Biopharmaceuticals. Verified for Agilent 1260 Infinity II LC Bio-inert System. Sonja Schneider
Combining small-scale purification and analysis of monoclonal antibodies on one instrument Protein purification with high-volume injection using the Agilent 126 Infinity Bio-inert Quaternary LC System
More informationOverview of preparative HPLC. Analytical Technologies Limited
Overview of preparative HPLC Analytical Technologies Limited 1.Review of liquid phase chromatography origin develop prospect Mobile phase Tewett 1903 Stationa ry phase origin Separation result Liquid-stationary
More informationGenerating Automated and Efficient LC/MS Peptide Mapping Results with the Biopharmaceutical Platform Solution with UNIFI
with the Biopharmaceutical Platform Solution with UNIFI Vera B. Ivleva, Ying Qing Yu, Scott Berger, and Weibin Chen Waters Corporation, Milford, MA, USA A P P L I C AT ION B E N E F I T S The ability to
More informationApplication Note. Kwasi Antwi, Amanda Ribar, Urban A. Kiernan, and Eric E. Niederkofler Thermo Fisher Scientific, Tempe, Arizona
Analysis of an Antibody Drug Conjugate using MSIA D.A.R.T. S. Technology, an Integral Part of Ligand Binding Mass Spectrometric Immunoassay (LB-MSIA) Workflow Application Note Kwasi Antwi, Amanda Ribar,
More informationVerification of Compendial Methods
Verification of Compendial Methods ภญ.ดร ดร.ส ภาณ ดวงธ รปร ชา ส าน กยาและว ตถ เสพต ด กรมว ทยาศาสตร การแพทย 7 ม ถ นายน 2556 1 Scopes : Overview Asean Analytical Validation Guidelines Verification of Compendial
More informationGas Chromatography Assignment Chem 543/443
Gas Chromatography Assignment Chem 543/443 1. Introduction Capillary gas chromatography (GC) is one of the most popular analytical techniques used in today s research. Its popularity is mainly due to efficient
More informationAppNote 5/2006 ABSTRACT
AppNote 5/26 Stir Bar Sorptive Extraction Based on Restricted Access Material for the Direct Extraction of Drugs and Metabolites in Biological Fluids Wayne M. Mullett and Elizabeth Kwong Merck Frosst,
More informationExploring Extra Sensitivity Using ionkey/ms with the Xevo G2-XS Q-Tof HRMS for Small Molecule Pharmaceutical Analysis in Human Plasma
Exploring Extra Sensitivity Using ionkey/ms with the Xevo G2-XS Q-Tof HRMS for Small Molecule Pharmaceutical Analysis in Human Plasma Yun Wang Alelyunas, Mark D. Wrona, Jim Murphy, Angela Doneanu, Gregory
More informationForced Degradation of Ibuprofen in Bulk Drug and Tablets
Forced Degradation of Ibuprofen in Bulk Drug and Tablets and Deteration of Specificity, Selectivity, and the Stability-Indicating Nature of the USP Ibuprofen Assay Method Sherri Farmer, Pamela Anderson,
More informationQuantitation of cyanotoxins in drinking water according to EPA 544 guidelines
APPLICATION NOTE 64968 Quantitation of cyanotoxins in drinking water according to EPA 544 guidelines Authors Ali Haghani, 1 Andy Eaton, 1 Neloni Wijeratne, Claudia Martins 1 Eurofins Eaton Analytical,
More informationChromatography Column Performance and Data Analysis Success Guide. Hints and Tips for Better Purifications
Chromatography Column Performance and Data Analysis Success Guide Hints and Tips for Better Purifications This Chromatography Success Guide provides practical advice on preparative chromatography and protein
More informationProtocol for Quantitative Determination of Residual Solvents in Cannabis Concentrates Prepared by: Amanda Rigdon, May 23 rd, 2016
Protocol for Quantitative Determination of Residual Solvents in Cannabis Concentrates Prepared by: Amanda Rigdon, May 23 rd, 2016 1.0 Method background: This method employs full evaporation technique headspace
More informationThermo Scientific Peptide Mapping Workflows. Upgrade Your Maps. Fast, confident and more reliable peptide mapping.
Thermo Scientific Peptide Mapping Workflows Upgrade Your Maps Fast, confident and more reliable peptide mapping. Smarter Navigation... Peptide mapping is a core analytic in biotherapeutic development.
More informationHPLC to UPLC Method Migration: An Overview of Key Considerations and Available Tools
HPLC to UPLC Method Migration: An Overview of Key Considerations and Available Tools Dr. Michael Swartz, Ph. D. Principal Consulting Scientist Worldwide Pharmaceutical Business Operations Waters Corporation
More informationSimultaneous in vivo Quantification and Metabolite Identification of Plasma Samples Using High Resolution QTof and Routine MS E Data Analysis
Simultaneous in vivo Quantification and Metabolite Identification of Plasma Samples Using High Resolution QTof and Routine MS E Data Analysis Mark Wrona, 1 Paul Rainville, 1 Eric Langlois, 2 Nigel Ewing,
More informationBio-Monolith Protein G Column - More Options for mab Titer Determination
Bio-Monolith Protein G Column - More Options for mab Titer Determination Application Note Biologics and Biosimilars Author Phu T. Duong Agilent Technologies, Inc. Introduction In recent years, monoclonal
More informationPART II: SAMPLING AND SALIVA SAMPLE PRETREATMENT
PART II: SAMPLING AND SALIVA SAMPLE PRETREATMENT IBIB PAN PROJECT TEAM A. MOOS 1, K. DUDZIŃSKI 2, P. KNIHNICKI 1, P. KOŚCIELNIAK 1,3, J. NOWAK 1, D.G. PIJANOWSKA 2, B. ROZUM 2, M. WIECZOREK 1, R. WIETECHA-POSŁUSZNY
More informationDynamic High Capacity Mustang Q Membrane Units for Scaleable Anion Exchange Chromatography Purification of Adenoviral Vectors
Contact Us: www.pall.com/contact Dynamic High Capacity Mustang Q Membrane Units for Scaleable Anion Exchange Chromatography Purification of Adenoviral Vectors Dynamic High Capacity Mustang Q Membrane Units
More informationSaudi Journal of Medical and Pharmaceutical Sciences. Research Article. Available Online: 70
Saudi Journal of Medical and Pharmaceutical Sciences Scholars Middle East Publishers Dubai, United Arab Emirates Website: http://scholarsmepub.com/ ISSN 2413-4929 (Print) ISSN 2413-4910 (Online) Research
More informationValidation Report 16
EURL for Cereals and Feeding stuff National Food Institute Technical University of Denmark Validation Report 16 Determination of pesticide residues in wheat, barley and rice by GC-MS/MS and LC-MS/MS (QuEChERS
More informationAnalysis of 16 Pesticide Residues in Broccoli Using CarbonX dspe QuEChERS AOAC Kits Using GC/MS
Analysis of 16 Pesticide Residues in Broccoli Using CarbonX dspe QuEChERS AOAC Kits Using GC/MS Authors: Conor Smith, Doug Fryer United Science Corp. 15911 Furuby Rd. Center City, MN 55012 USA Abstract
More information[ product solution ] Waters Oasis µ Elution PlateS. Patented Innovation. Elution volume as low as 25 μl. No evaporation and reconstitution
[ product solution ] Waters µ Elution PlateS Elution volume as low as 25 μl No evaporation and reconstitution Ideal for small sample volumes Up to a 15x increase in concentration Patented Innovation Now
More informationSeparation and Quantitation of a Mixture of Alcohols by Gas Chromatography
Separation and Quantitation of a Mixture of Alcohols by Gas Chromatography 1. Purpose This procedure will determine the percentage of two alcohols in an unknown aqueous mixture. 2. Background Gas chromatography
More informationICH Guideline S3A: Note for guidance on toxicokinetics: the assessment of systemic exposure in toxicity studies - questions and answers
14 December EMA/CHMP/ICH/320985/2016 Committee for Medicinal Products for Human Use ICH Guideline S3A: Note for guidance on toxicokinetics: the assessment of systemic exposure in toxicity studies - questions
More informationAnalysis of the bioactive components from different growth stages of Fritillaria taipaiensis P. Y. Li
Acta Pharmaceutica Sinica B 2013;3(3):167 173 Institute of Materia Medica, Chinese Academy of Medical Sciences Chinese Pharmaceutical Association Acta Pharmaceutica Sinica B www.elsevier.com/locate/apsb
More informationMaximizing Chromatographic Resolution of Peptide Maps using UPLC with Tandem Columns
Maximizing Chromatographic Resolution of Peptide Maps using UPLC with Tandem Columns Hongwei Xie, Martin Gilar, and Jeff Mazzeo Waters Corporation, Milford, MA U.S. APPLICATION BENEFITS The ACQUITY UPLC
More informationA Fast and Robust Linear ph Gradient Separation Platform for Monoclonal Antibody (MAb) Charge Variant Analysis
A Fast and Robust Linear ph Gradient Separation Platform for Monoclonal Antibody (MAb) Charge Variant Analysis Shanhua Lin, Julia Baek, and Chris Pohl Thermo Fisher Scientific, Sunnyvale, CA, USA Overview
More informationR R Innovation Way P/N SECKIT-7830 Newark, DE 19711, USA Tel: Fax: Website: Published in November 2013
5-100 Innovation Way Newark, DE 19711, USA Tel:302-3661101 Fax:302-3661151 Website: www.sepax-tech.com Published in November 2013 P/N SECKIT-7830 These Phases are developed based on innovative surface
More informationLabChip GXII: Antibody Analysis
WHITE PAPER LabChip GXII: Antibody Analysis Antibody Analysis using microfluidic technology in high throughput Quality by Design Experiments Abstract Current initiatives in Process Analytical Technology
More informationQualification of High-Performance Liquid Chromatography Systems
Qualification of High-Performance Liquid Chromatography Systems L. Huber Hewlett- Packard GmbH, Waldbronn December 1998 Manuscript of an article published in BioPharm, Vol 11 Number 11, November 1998,
More informationProtein-Pak Hi Res HIC Column and HIC Protein Standard
Protein-Pak Hi Res HIC Column and HIC Protein Standard CONTENTS I. INTRODUCTION II. a. Mobile Phase b. Flow Direction CONNECTING COLUMN TO LC SYSTEM I. INTRODUCTION This offering contains non-porous, polymethacrylate-based
More informationMethod Translation in Liquid Chromatography
Method Translation in Liquid Chromatography Technical Overview Abstract Ronald E. Majors Agilent Technologies, Inc. 2850 Centerville Rd Wilmington, DE 19808 USA With the recent emphasis on high performance
More informationQUESTIONS AND ANSWERS TO ICH S3A: NOTE FOR GUIDANCE ON TOXICOKINETICS: THE ASSESSMENT OF SYSTEMIC EXPOSURE IN TOXICITY STUDIES FOCUS ON MICROSAMPLING
INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE QUESTIONS AND ANSWERS TO ICH S3A: NOTE FOR GUIDANCE ON TOXICOKINETICS: THE ASSESSMENT
More informationUHPLC Separation of Triazine Herbicides at Elevated Temperature
Application ote: 453 UPLC Separation of Triazine erbicides at Elevated Temperature Dave Thomas, Thermo Fisher Scientific, San Jose, CA USA Key Words Accela UPLC Environmental Analysis erbicides igh Temperature
More informationA2LA. R231 Specific Requirements: Threat Agent Testing Laboratory Accreditation Program. December 6, 2017
Laboratory Page 1 of 17 Laboratory December 6, 2017 2017 by A2LA All rights reserved. No part of this document may be reproduced in any form or by any means without the prior written permission of A2LA.
More informationValidation of Thin Layer Chromatographic Procedures
Validation of Thin Layer Chromatographic Procedures International Symposium for High-Performance Thin-Layer Chromatography HPTLC 2011 July 7th, 2011, Basle Topics ICH Q2(R1) and nothing else? Other guidance
More informationFast Preparative Column Liquid Chromatography (PCLC)
Fast Preparative Column Liquid Chromatography (PCLC) Application Note 224 Joan Stevens, Ph.D. and Gary Scharrer Introduction Preparative HPLC is recognized as a prime method for obtaining pure compounds
More information